Briefing on Non-reproductive Cloning

November 2000

Introduction

The idea of cloning embryos in order to extract tissues for transplantation is extremely controversial in Britain and around the world. Many people fear that it is a step towards cloned babies and there is widespread feeling that it represents a moral degradation of human life. There are also scientific and legal issues that are currently poorly understood.

Britain is taking an international lead in developing this technology, and this has already attracted concern from other European countries: in September the European Parliament passed a motion censuring the British government for pressing ahead so quickly1.

The aim of this briefing is to clarify some of these issues and to suggest a possible solution: that there should be a moratorium on non-reproductive cloning until there is a global ban on cloning babies and until there has been a chance for a better informed public debate. We argue that a moratorium would not harm progress towards treatments for disease.

1. Terminology

In this briefing, we use the term non-reproductive cloning (NRC) to denote the process of (i) creating an embryo by cloning, followed by (ii) extraction of embryonic stem (ES) cells from that embryo, and the use of the ES cells to produce tissues for transplantation. CAHGE is unhappy with the use of the term ‘therapeutic cloning’. Attaching the heavily value-laden word ‘therapeutic’ tends to silence legitimate concerns about ethical and social issues. The more recent term, ‘Cell Nuclear Replacement’ adopted by the Donaldson committee2 is confusing to most people since it attempts to avoid the use of the word cloning, which most people associate with this technology.

2. What is non-reproductive cloning?

Cloning is the process of replacing the genetic material of an egg cell with the genetic material of a cell from another embryo, foetus, or an adult. The result is an embryo that is genetically identical to the embryo, foetus or adult from which the new genetic material came.

In NRC, an embryo created in this way would be allowed to grow outside the body until it contained around 100 cells. Amongst these are special cells, known as embryonic stem (ES) cells. In the second stage of the process, these cells would be extracted and grown in tissue culture. The extraction of ES cells would destroy the embryo. The ES cells can be induced to develop into all the different types of cell found in the body, and it is hoped that specialised cells, such as liver cells, could be used for transplantation into patients. If the cell used for creating the initial embryo came from the patient, the liver cells produced would be genetically the same as the patient’s and so would not be rejected by the patient’s immune system, thus circumventing one of the major problems in transplantation.

An alternative to creating a cloned embryo for each patient would be to use embryos left over from IVF to create banks of ES cells which contained all possible combinations of the proteins that determine whether transplanted tissue matches the patient’s immune system. This solution was advocated by the Royal Society as a matter of urgency in its submission to the Donaldson committee.

3. What are the alternatives?

We should always remember that large reductions in the incidence of disease can be achieved by addressing its environmental and social causes, and this is always preferable to high-tech medical treatments. It is certain that approaches involving NRC will be extremely expensive, and it is important that they are not allowed to detract or divert resources from from the application of preventive medicine or simpler treatments.

A potentially much simpler solution that NRC is to use adult stem cells from the patient themself. Many organs of the adult body contain stem cells that develop into a narrower range of cell types than ES cells. For example, bone marrow stem cells develop into all the different types of cells found in the blood, but not, normally, nerve or liver cells. Until recently it was believed that such adult stem cells could not change into cells found in another organ. However, in the last two years an increasing number of research papers have been published showing that this is incorrect, and that, for example, neural stem cells can turn into blood cells and muscle cells.

4. What are the pros and cons of adult and embryonic stem cells?

We should be clear that both of these possibilities are still at a very early stage of development. To date there are only three papers in the scientific literature describing the isolation of human ES cells, even though mouse ES cells have been used for more than 15 years. Human adult stem cells are already being used clinically, but their ability to develop into cells from other organs is a new discovery. Unfortunately, there has been a huge amount of hype surrounding the idea of NRC and many patients, such as those suffering from Parkinson’s disease, have been led to believe that they may personally benefit from treatments based on ES cells. It is unlikely that this will happen, since there is at least ten years of fundamental research and development needed before such techniques are clinically applied.

Many scientists are excited by the potential of NRC to tackle medical problems for which we currently have no good solution. However, ES cells have a number of drawbacks which have not been sufficiently acknowledged. The first of these is that we do not know how to control the way that ES cells develop into different cell types. It is not certain that we will ever be able to do this reliably, and it will be extremely technically difficult to produce 100% pure populations of a particular type of cell. It has also been suggested that we will be able to produce whole organs for transplantation, but this presents an even greater challenge, because organs contain different types of cells in a complex architecture. A further problem with ES cells is their tendency to form tumours when transplanted; that is why it would be essential to produce 100% pure cultures of specialised cells. Other problems with ES cells produced by cloning is that the cloning process may lead to abnormal cell behaviour. Many of the animals produced by cloning have been abnormal or have died very shortly after birth. These problems mean that cells derived from ES cells would have to be very extensively tested before they could be used for transplantation.

It is clear that adult stem cells are not as versatile as ES cells. However, this may be an advantage, since they may be easier to control. Adult stem cells are not currently available in large quantities and grow slowly, so it is not certain that it will be possible to create sufficient tissue for transplantation.

In summary, both stem cell approaches have potential and both face major challenges. The NRC approach is extremely ambitious and involves many entirely new techniques. It is by no means certain that it will ever be made to work. We are very concerned by the recent report of the Royal Society3 which attempted to talk down adult stem cells whilst glossing over the problems with NRC. CAHGE's analysis of the Royal Society report can be found on our website.

5. The legal situation - there will be no "free vote on cloning"

It is certainly clear that the public is primarily concerned about the risks and ethical issues raised by creating embryos by cloning, followed by their destruction, rather than by the use of ES cells to create tissues for transplantation. Following the publication of the Donaldson committee report in August, it was widely reported that the government would allow MPs a ‘free vote on cloning’, in order to allay public feeling that their key ethical concerns were not being democratically debated. Although the Donaldson report clearly states otherwise, the public has been given the impression that creation of embryos by cloning is currently illegal and MPs will be voting on whether or not to legalise it. This is not the case.

In fact, in December, MPs will only be allowed to vote on the narrow issue of whether embryo research should be permitted for the purpose of developing treatments for disease. Such research might not even involve stem cells. Furthermore, cloning, using the technique used to create Dolly the sheep, is currently perfectly legal, provided that the HFEA grants a licence. This is because, when the HFE Act was passed in 1990, it only outlawed a different cloning technique (in which the new genetic material is inserted after rather than before fertilisation, as was done with Dolly). Thus, at present, it is within the gift of the HFEA to allow the creation of embryos by cloning. Following the government’s acceptance of the Donaldson report, we can expect applications to do this to be made in the near future, and to be handled by the HFEA without publicity. The public’s expectation that MPs will be able to debate and legislate on their key concerns will not be realised. It is therefore imperative that MPs press the government to allow a free vote on the key issue of the creation of embryos by cloning, and not just on the question of the purposes of embryo research.

6. The danger of reproductive cloning

It is clear that the main reasons why the public is concerned about NRC is the risk that someone will clone a baby. Reproductive cloning is widely regarded as abhorrent, and public opinion polls around the world continue to show strong public opposition to the practice. (For articles explaining why reproductive cloning should not be permitted, please visit the CAHGE website - www.users.globalnet.co.uk/~cahge/cloning) UNESCO and the WHO have also issued statements condemning reproductive cloning. In Europe, members of the Council of Europe (CoE) agreed in 1997 a Convention on Human Rights and Biomedicine, which has a protocol banning reproductive cloning. Most members of the CoE have now signed this protocol, but the British government is dragging its feet, for reasons which are unclear. The government should be urged to immediately sign the Convention and its Protocol.

Once British scientists had developed the techniques for creating viable human embryos by cloning, it would be technically far easier to implant such cloned embryos into a woman in order to create a baby than to produce tissues for transplantation from them. Thus, allowing British scientists to overcome the key technical hurdle to cloning a baby risks the immediate application of their work for reproductive cloning purposes. In its response to the Donaldson committee report, the government stated its view that current UK controls were sufficient, and that it would strengthen them by introducing a legal ban on reproductive cloning ‘when parliamentary time permits’. However, the legality of reproductive cloning in the UK would be irrelevant to US entrepreneurs who face no legal restrictions whatsoever. In fact, a cult, the Raelians, have recently stated their intention to clone a baby in the USA. Were they or others to do this, based on the work of British scientists, those scientists and the British government would no doubt disclaim responsibility for what had happened. It would be complacent and irresponsible in the extreme to permit British scientists to clone embryos until we have an enforceable global ban on reproductive cloning. MPs should press the government to lead international efforts for such a ban, and to give assurances that British scientists will not be permitted to clone embryos until such a ban is place.

7. Would a moratorium on cloning harm progress towards treatments for disease?

It is sometimes suggested that a moratorium on creating cloned embryos would harm progress towards the overall goal of creating tissues for transplantation. However, this is not case. For at least five years scientists working on NRC will be occupied tackling the major technical problems mentioned in section 4 above. They can do this work using ES cells derived from surplus embryos from IVF. To develop a technique for creating viable cloned embryos will undoubtedly take large resources, but given the ability to clone an increasing number of animals, is not expected to take a very long time. Until the technical hurdles involved in creating tissues for transplantation have been overcome, the cloning aspect is essentially irrelevant, and can therefore wait until a global ban on reproductive cloning is in place.

8. How is the moral status of embryos affected by non-reproductive cloning?

CAHGE is not a "pro-life" organisation, and we do not believe that embryos have the same moral status as human beings. It is unfortunate that because the debate in the media on this issue has been dominated by pro-life organisations and scientists, the impression has been given that it is only those who believe that the embryo is a person who have ethical concerns about cloning and then destroying embryos. We believe that the majority of the public occupies a middle ground between the two polarised extremes, but unfortunately their views have barely been heard.

In fact, current UK law is based on the concept that embryos must be treated with respect, even though they are not regarded as persons. We would argue that the creation of embryos purely as a source of biological material degrades their moral status, since it makes them nothing more than means to achieving the desired end. It would seem ridiculous to speak of respect for something that has been created simply in order to extract certain useful cells: it becomes a mere thing. The US Patent and Trademark Office has already stated that it would grant patents on human embryos, and this year has seen the revelation that several companies, as well as the leading ES cells researcher in this country, have sought patents on human embryos. This concern about instrumentalising embryos is the reason why all European countries with the exception of the UK prohibit the creation of embryos solely for purposes of research. Even in Britain, this has been done extremely rarely, but it would massively increase if NRC were to be widely used.

It should be noted that the use of surplus embryos for research does not degrade embryos' moral status in the same way. In this case their essential function and moral meaning as potential human beings, which is defined by the purpose for which they were created, is not affected.

Another way of understanding this concern is that NRC turns reproduction, with all its social and human significance, into just another production process. The production of tissues for transplantation through NRC, although it would produce individually customised products, is nonetheless a production process which would operate on an industrial scale.

Whilst the Donaldson committee recognised these concerns, it did not adequately address them. Instead it simply adopted the utilitarian argument that humans would benefit medically from the reduction of embryos’ moral status. Whilst medical benefit is a relevant moral consideration, it is not the only one. We believe that the tendency to turn human life into a mere thing is part of a broader tendency promoted by reproductive and genetic technologies. The implications of such a trend for our concepts of human dignity and human rights need to be taken extremely seriously. This does not mean that NRC is automatically ethically unacceptable, but this issue clearly deserves more public debate than it has received to date. We believe that it is vital that there be such a public debate before NRC is allowed to proceed.

References

3. "Stem cell research and therapeutic cloning: an update’ Royal Society document 12/00, November 2000.

Further copies of this briefing can be obtained from The Campaign Against Human Genetic Engineering PO Box 6313 London N16 0DY Phone: (44) (0)208 809 4513, or downloaded from our website: http://www.users.globalnet.co.uk/~cahge